MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2017-10-05 for RESQPUMP manufactured by .
[89466210]
The tresqpump appeared in good condition with no obvious signs of damage or tampering. The force gauge was zeroed when first removed from the box. When the pump was compressed to 50 kg, the force gauge would slowly return to zero after the force was removed. After additional compressions, this issue would decrease in frequency but not cease completely. The gauge also wouldn't move when the pump was placed under a decompression force of -15 kg. After taking the clamshell apart, all components seemed to be in the correct orientation. The pushrod could be removed but was slightly more difficult to do than average. A significant portion of the stem was covered with an excessive amount of loctite. When the pump was reassembled, it seemed to be working correctly. The decompression issue also seemed to be resolved. The accuracy of the force gauge was verified on a scale and had the following results which are within specification: force gauge = 50 kg: scale = 47 kg and force gauge = -15 kg: scale = -16 kg. The investigation suggests that an excessive amount of loctite was put on the pushrod stem causing the force gauge to return slowly to zero.
Patient Sequence No: 1, Text Type: N, H10
[89466331]
Medics called to scene of a full arrest. Gauge on resqpump was not working, seemed stuck. It is reported that the resqpump was not used on the patient. Notified the customer of a stuck gauge.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003477173-2017-00006 |
| MDR Report Key | 6918766 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2017-10-05 |
| Date of Report | 2017-09-05 |
| Date of Event | 2017-09-06 |
| Date Mfgr Received | 2017-09-22 |
| Date Added to Maude | 2017-10-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS DIANE HOWELL |
| Manufacturer Street | 1905 COUNTY ROAD C WEST |
| Manufacturer City | ROSEVILLE MN 55113 |
| Manufacturer Country | US |
| Manufacturer Postal | 55113 |
| Manufacturer Phone | 6514035600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RESQPUMP |
| Generic Name | RESQPUMP |
| Product Code | PIZ |
| Date Received | 2017-10-05 |
| Device Availability | * |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-10-05 |